Ranbaxy Laboratories Ltd has received approval from the US Food & Drug Administration to manufacture and market Metformin Hydrochloride Extended-release Tablets, 750 mg.
According to the company release, the Office of Generic Drugs, US Food and Drug Administration, has determined the Company's formulation to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Glucophage XR Extended-release Tablets, 750 mg. Total annual market sales for Metformin XL Tablets were $ 227 million (-49%) with market sales of Metformin XL Tablets 750 mg of $ 29.0 million (+61%). (IMS - MAT: March 2005).
Merformin hydrochloride extended release tablets, as monotherapy, are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. The product may be used concomitantly with a sulfonylurea or insulin to improve glycemic controlin adults (17 years of age and older).
"It also marks a major milestone as the 100th ANDA approval held by RLL allowing us to market another ethical product under the Ranbaxy label in the US. Our plans are to introduce this product when quantities are sufficient to support market demand,” said Jim Meehan, Vice President of Sales and Marketing for Ranbaxy Pharmaceuticals Inc., USA.